aPROMISE X
K-Number: K220590 · 2022-04-29
ApplicantExini Diagnostics AB
Decision Date2022-04-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
aPROMISE X is a medical device manufactured by Exini Diagnostics AB. It received FDA 510(k) clearance on 2022-04-29 under approval number K220590. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the aPROMISE X?
aPROMISE X is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Exini Diagnostics AB. The 510(k) number is K220590.
When was aPROMISE X approved by the FDA?
aPROMISE X received FDA 510(k) clearance on 2022-04-29, under approval number K220590.
What company makes aPROMISE X?
aPROMISE X is manufactured by Exini Diagnostics AB.
What is the FDA product code for aPROMISE X?
The FDA product code for aPROMISE X is LLZ.
Other Devices by Exini Diagnostics AB
Related Devices (Code: LLZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.